Finding studies
Finding studies
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Lead
Eurofarma Laboratorios S.A.
This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE). The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim. The secondary endpoints considered for the study will be: * The febrile neutropenia rate; * The rate of any grade 4 neutropenia; * The duration of the grade 4 neutropenia; * The frequency of the adverse events and the laboratory changes.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
